2017 Regional Chain Conference Strategic Partners Profiles FLOOR PLAN
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Alkermes Public Limited Company
ALKERMES PUBLIC LIMITED COMPANY Directors’ Report and Consolidated Financial Statements For the Year Ended March 31, 2013 ALKERMES PLC Table of Contents Page Directors’ Report .......................................................... 2 Statement of Directors’ Responsibilities .......................................... 56 Independent Auditors’ Report—Group ........................................... 57 Consolidated Profit and Loss Account ........................................... 59 Consolidated Statement of Comprehensive Income (Loss) ............................. 60 Consolidated Balance Sheet ................................................... 61 Consolidated Statement of Cash Flows ........................................... 63 Consolidated Reconciliation of Shareholders’ Funds ................................. 62 Notes to the Consolidated Financial Statements .................................... 64 Independent Auditors’ Report—Company ......................................... 111 Company Balance Sheet ..................................................... 113 Notes to the Company Financial Statements ....................................... 114 1 DIRECTORS’ REPORT For the Year Ended March 31, 2013 The directors present their report and audited consolidated financial statements for the fiscal year ended March 31, 2013. The directors have elected to prepare the consolidated financial statements in accordance with section 1 of the Companies (Miscellaneous Provisions) Act, 2009, which provides that a true and fair view of the state of -
In Re: Alkermes Securities Litigation 03-CV-12091-Consolidated
Case 1:03-cv-12091-RCL Document 39 Filed 07/12/2004 Page 1 of 49 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS In re ALKERMES SECURITIES ) Master Docket No. 03-CV-12091-RCL LITIGATION ) ) CLASS ACTION This Document Relates To: ) ) ALL ACTIONS. ) ) ) CONSOLIDATED COMPLAINT FOR VIOLATION OF THE FEDERAL SECURITIES LAWS Case 1:03-cv-12091-RCL Document 39 Filed 07/12/2004 Page 2 of 49 SUMMARY AND OVERVIEW 1. This is a securities class action on behalf of all purchasers of the common stock of Alkermes, Inc. (“Alkermes” or the “Company”) between April 22, 1999 and July 1, 2002 (the “Class Period”), against Alkermes and certain of its officers and directors for violations of the Securities Exchange Act of 1934 (the “Exchange Act”). 2. Alkermes is a biopharmaceutical company focused on the development of controlled- release drug delivery technologies and their application to existing or new drug therapies. Among the drug delivery technologies defendants seek to develop are sustained-release systems based on biodegradable polymeric microspheres, including those based on Medisorb polymers. 3. In 1996, Alkermes entered into an agreement with JPI Pharmaceutical International (“Janssen”), an affiliate of pharmaceutical giant Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (“Johnson & Johnson”), to develop an injectable form of the schizophrenic drug Risperdal, based upon the Medisorb polymer technology, called Risperdal Consta. Janssen has marketed the oral form of Risperdal since 1993, with sales of $2.3 billion in 2003. According to a December 12, 2001 report by analysts Thomas Weisel Partners, LLC (“Thomas Weisel”), during the Class Period, oral Risperdal was the most prescribed drug in the $5.3 billion atypical antipsychotic market. -
Explanation of Conflict of Interest Disclosure Parts: Part One: All
Explanation of Conflict of Interest Disclosure Parts: Part One: All Financial Involvement with a pharmaceutical or biotechnology company, a company providing clinical assessment, scientific, or medical companies doing business with or proposing to do business with ACNP over past 2 years (Jan. 2011-Present) Part Two: Income Sources & Equity of $10,000 or greater Part Three: Financial Involvement with a pharmaceutical or biotechnology company, a company providing clinical assessment, scientific, or medical products or companies doing business with or proposing to do business with ACNP which constitutes more than 5% of personal income (Jan. 2011-Present): Part Four: Grants from pharmaceutical or biotechnology company, a company providing clinical assessment, scientific, or medical products directly, or indirectly through a foundation, university, or any other organization (Jan. 2011-Present) Part Five: My primary employer is a pharmaceutical/biotech/medical device company. 2012 Program Committee Disclosures Anissa Abi-Dargham: Part 1: Pfizer; Otsuka; Takeda; Sunovion; Shire; Roche; Pierre Favre; Part 2: Pierre Favre William Carlezon: Part 1: Referring to 2010-2011: Scientific Advisory Board, Myneurolab.com; Consultant, Concert Pharmaceuticals; Consultant, Lantheus Medical Imaging; Consultant, Transcept Pharmaceuticals, (Spouse) Senior Scientist, EMD Serono; Part 2: (Spouse) Senior Scientist, EMD Serono, Part 3: (Spouse) Senior Scientist, EMD Serono Cameron Carter: Part1: GlaxoSmithKline research; Part 4: GlaxoSmithKline Karl Deisseroth: Part -
Managing Pharmacy Automation and Informatics 271
Managing Pharmacy 15 Automation and Informatics Dennis A. Tribble and Mei-Jen Ho CONTENTS Framework for Health-System Pharmacy Automation .......................................... 270 Technology is a Tool ......................................................................................... 271 Be Careful: Technology Will Change the Way the Work is Performed ............ 271 Technology Requires Infrastructure .................................................................. 271 The Adoption of Pharmacy Technology Requires the Involvement of Stakeholders Outside of the Pharmacy .........................................................272 Technology Platforms are Less Important than What the Technology Can Do ...................................................................................................................272 Technology Systems Should Operate from a Single, Reliable Source of Truth on All Data .......................................................................................... 273 Interoperability is the Key to Success .......................................................... 273 Regulation of Technology and Medical Devices ................................................... 274 Other Regulatory Considerations ...................................................................... 276 State Laws .................................................................................................... 276 Drug Enforcement Agency (DEA) Regulations ...........................................277 Privacy and Security of -
Corporate Responsibility Report
Corporate Responsibility Report October 2019 ©2019 Alkermes. All rights reserved. Table of Contents Section 1: Introduction . 2 Section 2: About Our Company . 3 Section 3: Our Approach to Corporate Responsibility . 4 Section 4: Environment . 6 Section 5: Social . 15 Section 6: Governance . 23 Section 7: The Future of Corporate Responsibility at Alkermes and About This Report . 27 ALKERMES • CORPORATE RESPONSIBILITY REPORT 1 SECTION 1 INTRODUCTION A Message from Our CEO Alkermes was founded by pioneers in the field of Inspired by the courage and determination of individuals neuroscience, and their legacy of innovation and in these frequently underserved and marginalized scientific excellence — applied to the real-world needs communities, we are driven to develop medicines and of patients — remains central to our mission. Alkermes contribute to systemic solutions that we hope will have technologies and discoveries have contributed to a meaningful impact on the lives of patients. important medicines that continue to shape the treatment landscape in many disease areas. Today, Our Commitment we are distinguished from other biopharmaceutical As we look toward building our business for the companies by our core focus on serious mental illness future, we are guided by the opportunity — and what and addiction — chronic, highly prevalent conditions we believe is our responsibility — to help address the that affect millions of people and represent some of unmet needs of patients and to operate in a sustainable, the most challenging public health issues of our time. socially responsible manner. We firmly believe that doing so is best for our business, our employees, for Great science. Deep compassion. -
Implementation of a Pharmacy Automation System (Robotics) to Ensure Medication Safety at Norwalk Hospital
Q Manage Health Care Vol. 18, No. 2, pp. 103–114 c 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins Implementation of a Pharmacy Automation System (Robotics) to Ensure Medication Safety at Norwalk Hospital Robert J. Bepko, Jr, BS, MHA, RPh; John R. Moore, BS, MHA, RPh; John R. Coleman, PhD This article reports an intervention to improve the CURRENT INDUSTRY TRENDS quality and safety of hospital patient care by introducing the use of pharmacy robotics into the The Institute of Medicine reported in 1999 that medication distribution process. Medication safety there are more than 98 000 preventable medical er- is vitally important. The integration of pharmacy rors that occur annually in US Hospitals, that 10% robotics with computerized practitioner order entry of hospitalized patients suffer medication-related in- and bedside medication bar coding produces juries, and that more than 7000 patients die annu- ally because of medication errors.1 A recent study a significant reduction in medication errors. found that the leading cause of anxiety for patients is The creation of a safe medication—from initial the fear of suffering a medication error during their ordering to bedside administration—provides hospital stay. Evidence suggests this fear may be jus- enormous benefits to patients, to health care tified. Researchers who observed nurses delivering providers, and to the organization as well. medications to patients in 36 health care facilities in the Greater Atlantic and Denver metropolitan areas made some startling findings. Almost 1 in 5 medi- cations was given erroneously, and 7% of the mis- takes were potentially harmful.2 Investigators at Har- vard found that most medication errors occur either when a physician inaccurately ordered a medication (39%) or when a nurse administered a drug mistak- enly (38%). -
Commercial Products
Website www.alkermes.com Ticker Symbol (NASDAQ) ALKS Alkermes, Inc. is a fully integrated biotechnology company that develops medicines designed to yield better outcomes Contacts and improve patients’ lives. Our products, which use novel molecules and innovative drug technologies, target Rebecca Peterson Vice President, Corporate widespread diseases including central nervous system (CNS) disorders, addiction and diabetes. We approach the drug Communications development process from a patient-centric perspective, beginning with a thorough understanding of the challenges Voice: 617-583-6378 patients face on a day-to-day basis. Our products are designed with patient needs and behaviors in mind, with the goal Blair Jackson of ensuring that patients consistently take their medication for long-term treatment success. Vice President, Business Development Alkermes has multiple partnered programs and also works independently to develop and commercialize proprietary Voice: 617-250-1594 products. The company has built a wide range of capabilities, including innovative research programs, clinical development, large-scale manufacturing, and a commercial presence in the marketplace. Corporate Headquarters Alkermes, Inc. 88 Sidney Street Cambridge, MA 02139 VIVITROL® Voice: 617-494-0171 Commercial Products (naltrexone for extended-release injectable suspension) Fax: 617-494-9263 RISPERDAL® CONSTA® [(risperidone) long-acting injection] Product: VIVITROL is an injectable formulation of naltrexone, based on Alkermes’ unique Medisorb Product: RISPERDAL CONSTA is a long-acting injectable technology. VIVITROL is designed for once-monthly form of Johnson & Johnson’s schizophrenia drug, dosing, eliminating the need for patients to make a RISPERDAL. Developed utilizing Alkermes’ proprietary daily decision about taking their medicine. Alkermes Medisorb® technology, RISPERDAL CONSTA is manufactures VIVITROL at its commercial facility in Ohio administered once every two weeks, rather than daily, and markets the product independently in the U.S. -
Central Pharmacy Automation As a Service
Central Pharmacy Automation as a Service A New Path Forward Executive Summary 3 Contents 1 2 Challenges of the Central Pharmacy 4 3 Goal of the Autonomous Pharmacy 5 4 Challenges to Adopting Pharmacy Automation 6 5 Technology with Service Delivers Best Outcomes 8 6 Conclusion 9 Citations 10 1 Executive The healthcare industry is undergoing a Summary monumental shift. The introduction of automation into hospital pharmacy workflows is transforming care, freeing up time for pharmacists to engage in more clinical initiatives that improve patient outcomes. The journey towards a zero-error central pharmacy reduces medication error and waste, but many pharmacies are still putting off the adoption of autonomous solutions. To overcome this reluctance, technology needs to be easy to adopt, flexible enough to adapt to the increasing complexities of the central pharmacy, and more directly establish new standards of care. Automation on its own is not enough. Hospitals and health systems must leverage new turnkey operational service models to optimize and maximize the benefit of automation technology. Leveraging new technologies within the as-a-service model will help unlock the human potential that leads to superior patient care and safety. 3 The central pharmacy is the hub of care that patients and providers depend on in any hospital facility. To keep it running smoothly, how- ever, there is a seemingly insurmountable number of challenges 2 that need to be overcome daily, stemming from a lack of inventory visibility into inventory and supply. Challenges of the The traditional solution to these challenges has been to increase Central Pharmacy administrative functions. -
Signatory Companies
PhRMA Direct to Consumer Advertising Principles Signatory Companies In October 2018, the PhRMA BoArd of Directors Adopted meAsures to enhAnce the PhRMA Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines. The revised, voluntAry Principles become effective on April 15, 2019. The revised, voluntAry Principles include A new guiding principle stAting thAt “[A]ll DTC television Advertising thAt identifies A prescription medicine by nAme should include direction as to where patients can find information about the cost of the medicine, such as a company- developed website, including the list price And Average, estimAted or typicAl pAtient out-of- pockets costs, or other context About the potentiAl cost of the medicine.” The Principles Also stAte thAt PhRMA will identify on its website All compAnies thAt voluntArily And independently commit to Abide by the Principles And will identify compAnies thAt complete, At the AppropriAte time, AnnuAl certificAtions thAt they hAve policies And procedures in plAce to foster compliAnce with the Principles. The following is A list of All signAtory compAnies who hAve Announced thAt they intend to Abide by the Principles: AbbVie GlAxoSmithKline Alexion Pharmaceuticals, Inc. Incyte CorporAtion Alkermes plc. Ipsen BiophArmAceuticAls, Inc. Allergan plc Johnson & Johnson Amgen Inc. Lundbeck Inc. Astellas Americas Merck & Co., Inc. AstrAZenecA PhArmAceuticAls LP NovArtis PhArmAceuticAls CorporAtion Bayer CorporAtion Novo Nordisk Inc. Biogen OtsukA AmericA PhArmAceuticAl, Inc. (OAPI) BioMArin PhArmAceuticAl Inc. Pfizer Inc Boehringer Ingelheim PharmAceuticAls, Inc. Purdue PhArmA L.P. Bristol-Myers Squibb CompAny Sanofi Celgene CorporAtion Sunovion Pharmaceuticals Inc. Daiichi SAnkyo, Inc. TakedA PhArmAceuticAls USA, Inc. EisAi Inc. TevA PhArmAceuticAls Eli Lilly And CompAny UCB EMD Serono . -
Schedule 14A Schedule 14A Information
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 (Amendment No. ) Filed by the Registrant ☑ Filed by a Party other than the Registrant o Check the appropriate box: ☑ Preliminary Proxy Statement o Confidential, for Use of the Commission Only (as permitted by Rule 14a- 6(e)(2)) o Definitive Proxy Statement o Definitive Additional Materials o Soliciting Material Pursuant to § Rule 14a-12 ALKERMES PLC (Name of Registrant as Specified In Its Charter) (Name of Person(s) Filing Proxy Statement if Other Than the Registrant) Payment of Filing Fee (Check the appropriate box): ☑ No fee required. o Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. (1) Title of each class of securities to which transaction applies: NOT APPLICABLE (2) Aggregate number of securities to which transaction applies: NOT APPLICABLE (3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined): NOT APPLICABLE (4) Proposed maximum aggregate value of transaction: NOT APPLICABLE (5) Total fee paid: NOT APPLICABLE o Fee paid previously with preliminary materials: NOT APPLICABLE o Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. -
Oral Presentation Disclosures
Oral Presentation Disclosures Adler, Lenard – Alcobra Pharma, APSARD/Pond Foundation, Major League Baseball, Major League Baseball Players Association, National Football League, New York University School of Medicine, Novartis Bioventures, Shire Pharmaceuticals, Sunovion, SUNY Upstate, Theravance, US Department of Veterans Affairs Cooperative Studies Program Anton, Raymond – Abbvie, Alkermes, Eli Lilly, Ethypharm, Lundbeck, Pfizer, Sunpharma Baker, Ross – Otsuka Pharmaceutical Development & Commercialization, Inc. Baldwin, David – Lundbeck Beaver, Jessica – Targacept, Inc. Bencherif, Merouane – Targacept, Inc. Bertolino, Alessandro – F. Hoffmann-La Roche, Ltd. Bradshaw, Mark – Euthymics Bioscience, Neurovance, Inc. Burdick, Katherine – Dainippon Sumitomo Pharma Bymaster, Frank – Euthymics Bioscience, Neurovance, Inc. Calabrese, Joseph – Sunovion, Teva (Cephalon) Cantillon, Marc – Forest, Kyowa, Lilly, Merck, Pfizer, Reviva Caroff, Stanley – Sunovion Chen, Yinzhong – Takeda Development Center Americas, Inc. Chengappa, Roy – Pfizer, Inc. Childress, Ann – Abbott Laboratories, Bristol Myer Squibb, GlaxoSmithKline, Ironshore, Janssen (Ortho-McNeil), Johnson & Johnson PRD, Lilly, Neos Therapeutics, Neurovance Inc., NextWave, Novartis, Noven, Otsuka, Pfizer, Rhodes, Sepracor, Shionogi, Shire, Somerset, Sunovion, Theravance Christine, Mazzucco – Janssen Cohen, Lee – Astra-Zeneca Pharmaceuticals, Bristol-Myers Squibb, Cephalon, Inc., GlaxoSmithKline, National Institute of Mental Health, National Institute on Aging, Noven Pharmaceuticals, Ortho-McNeil -
Product Brochures Pharmacy Automation Brochure
Greater Prescription Accuracy, Improved Operating Efficiency and Lowered Costs. For Pharmacies Serving LTC/ALF/SNF Kirby Lester Are you Capsa Healthcare, which brings you Kirby Lester automation, has been a leader in Pharmacy Automation ready for medication management for extended care settings for 50+ years. from Capsa Healthcare pharmacy automation? Best-selling Medication Carts • 3 unique cart lines Automation by Capsa Healthcare • Support any med delivery (punch cards, auto If any of these challenges occur in your packaging, unit dose box) pharmacy, you will benefit from • Tremendous capacity Rx filling automation. for storing medication and supplies □ Drug diversion potential • Easily add hardware □ C-II log is a 3-ring binder for computing/EMAR, and □ Still hand-counting by 5’s accessories □ Concerned about dispensing errors • Also: In-room medication cabinets for ALF □ Pharmacy insurance company suggested “risk-minimizing technology” □ Paid too much in taxes last year □ Pharmacist time wasted by correcting Stat Dose/1st Dose and Controls filling errors Management □ Want to free up time to grow business • NexsysADC, the practical automated dispensing □ Don’t use any verification software cabinet for extended care (barcode-scanning to check the stock bottle NDC with the order’s NDC) • Fully control the onsite storage and distribution of □ Daily Rx volume is rising Greater Prescription Accuracy, meds and supplies, at a □ Hard to fill staff vacancies fraction of the cost of Improved Operating Efficiency alternative ADCs □ Pharmacy environment